Biomerieux B.40 Software Update Recalled for Patient Mislabeling
Biomerieux Inc is recalling 22 B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error that could lead to incorrect patient identification, which is a moderate risk without reported injuries.
Plain-English summary
Biomerieux Inc is recalling 22 units of the B.40 software update (catalog number 412003) for the 3D IND USB-ML02 instrument. The recall is due to a software miscommunication that may cause patient information to be mislabeled on culture specimen bottles.
The affected software is used with an instrument commonly employed to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs and symptoms suggestive of bloodstream infection. The recall covers units distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact Biomerieux Inc for instructions on how to resolve the software issue. Consumers are not directly affected by this recall, as the product is intended for professional medical use.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients t
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Identified by B.40 firmware
Distribution
Part of a larger recall action
This product is one of 31 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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